Rosucol Warnings

Liver Enzymes: HMG CoA reductase inhibitors, like some other lipid-lowering therapies, have been associated with biochemical abnormalities of liver function. It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semi-annually) thereafter. Liver enzyme changes generally occur in the first 3 months of treatment with Rosuvastatin. Patients who develop increased transaminase levels should be monitored until the abnormalities have resolved. Should an increase in ALT or AST of >3 times ULN (upper limit of normal) persist, reduction of dose or withdrawal of Rosuvastatin is recommended. Rosuvastatin should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
Hepatic Insufficiency: Patients with active liver disease or unexplained persistent transaminase elevations are contraindications to the use of Rosuvastatin.
Myopathy/Rhabdomyolysis: Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with Rosuvastatin and with other drugs in this class. Uncomplicated myalgia has been reported in Rosuvastatin treated patients. Factors that may predispose patients to myopathy with HMG-CoA reductase inhibitors include advanced age (=65 years), hypothyroidism, and renal insufficiency. The incidence of myopathy increased at doses of Rosuvastatin above the recommended dosage range. Consequently: Rosuvastatin should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age, and hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. Rosuvastatin therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. The risk of myopathy during treatment with Rosuvastatin may be increased with concurrent administration of other lipid-lowering therapies or cyclosporine, the benefit of further alterations in lipid levels by the combined use of Rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of this combination. Combination therapy with Rosuvastatin and gemfibrozil should generally be avoided. The risk of myopathy during treatment with Rosuvastatin may be increased in circumstances which increase Rosuvastatin drug levels. Rosuvastatin therapy should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).